Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Cellectis manufactures its allogeneic UCART clinical trial supply and starting materials through contract manufacturing organizations (CMOs) but is now looking to securing inhouse supply through investments in Raleigh, North Carolina, and France.

Cellectis building plants in NC, USA and Paris, France

A spokesperson from the firm told this publication that the Raleigh facility, known as the IMPACT plant – Innovative Manufacturing Plant for Allogeneic Cellular Therapies – will be used for clinical and commercial production of Cellectis’ allogeneic UCART products when operational, expected by 2021.

The site will create up to 200 jobs, the spokesperson said, and while the level of the investment has not been disclosed Research Park Triangle publication WRAL TechWire puts the figure at $68 million (€60 million).

Meanwhile, the firm is building a plant in Paris, known as the SMART – Starting Material Realization for CAR-T products – facility, set to produce critical starting material supply for UCART clinical studies and commercial products.

“We are entering an exciting phase for Cellectis, internalizing manufacturing capabilities and capacity,” André Choulika, CEO of Cellectis, said in statement.

“Now is the right time to create our own supply competencies. By combining the state-of-the-art capabilities that IMPACT and SMART plants will provide, Cellectis will gain autonomy, control and expertise in manufacturing operations, allowing us to continue to build competitive advantage and remain the leader in our field.”

The firm will continue to use CMOs in unison with its own capabilities, we were told.

“These CMOs will continue to be strategic business partners, complementing IMPACT and SMART plants in assuring a robust supply chain for the manufacture of Cellectis’ allogeneic UCART therapies.”